Trial Outcomes & Findings for Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide (NCT NCT02379390)
NCT ID: NCT02379390
Last Updated: 2019-06-21
Results Overview
rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)
Results posted on
2019-06-21
Participant Flow
Study conducted at 6 active centers in United States and Canada. A total of 8 participants were enrolled between 17 June 2015 to 13 Mar 2016. Total 15 participants were screened, out of which 7 were screen failures and 8 were randomized and treated in the study. Study was terminated early due to very low recruitment rate in both countries involved.
Participants were randomized to receive either chemotherapy (cabazitaxel) or antiandrogen receptor targeted therapy (abiraterone or enzalutamide were assigned based on previous Androgen receptor \[AR\] targeted treatment in which participants previously treated with abiraterone were treated with enzalutamide and vice versa due to resistance).
Participant milestones
| Measure |
Cabazitaxel
Participants received Cabazitaxel 25 milligrams per meter square (mg/m\^2), intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 milligrams (mg) orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Abiraterone Acetate or Enzalutamide
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Cabazitaxel
Participants received Cabazitaxel 25 milligrams per meter square (mg/m\^2), intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 milligrams (mg) orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Abiraterone Acetate or Enzalutamide
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Investigator's decision
|
1
|
0
|
|
Overall Study
Study Termination
|
0
|
1
|
Baseline Characteristics
Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide
Baseline characteristics by cohort
| Measure |
Cabazitaxel
n=4 Participants
Participants received Cabazitaxel 25 mg/m\^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Abiraterone Acetate or Enzalutamide
n=4 Participants
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
PSA response was defined as decline of serum PSA from baseline by \>= 50 percent (%).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline upto progression or death due to any cause (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until the end of study (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Pain response was analyzed using the brief pain inventory-short form (BPI-SF).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until the end of study (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)Population: Planned analysis could not be performed due to early study termination.
Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.
Outcome measures
Outcome data not reported
Adverse Events
Cabazitaxel
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Enzalutamide or Abiraterone
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Abiraterone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Enzalutamide
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cabazitaxel
n=4 participants at risk
Participants received Cabazitaxel 25 mg/m\^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Enzalutamide or Abiraterone
n=4 participants at risk
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Abiraterone
n=1 participants at risk
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Enzalutamide
n=3 participants at risk
Participants received enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
Other adverse events
| Measure |
Cabazitaxel
n=4 participants at risk
Participants received Cabazitaxel 25 mg/m\^2, intravenously for 1 hour on Day 1 of each cycle (each cycle was of 3 weeks), plus prednisone 10 mg orally given daily until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Enzalutamide or Abiraterone
n=4 participants at risk
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Abiraterone
n=1 participants at risk
Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally continuously once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
Enzalutamide
n=3 participants at risk
Participants received enzalutamide 160 mg, orally continuously once daily from Day 1 to Day 21 in each treatment cycle (each cycle was of 3 weeks), until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Increased Tendency To Bruise
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Number of events 2 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Gastrointestinal disorders
Haematochezia
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Gastrointestinal disorders
Lip Pain
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
General disorders
Oedema Peripheral
|
50.0%
2/4 • Number of events 2 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
100.0%
1/1 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
50.0%
2/4 • Number of events 2 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
33.3%
1/3 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Nervous system disorders
Neuropathy Peripheral
|
50.0%
2/4 • Number of events 2 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Psychiatric disorders
Mood Swings
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
|
Vascular disorders
Hot Flush
|
0.00%
0/4 • Baseline until the end of study (maximum duration: 1059 days)
|
25.0%
1/4 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
100.0%
1/1 • Number of events 1 • Baseline until the end of study (maximum duration: 1059 days)
|
0.00%
0/3 • Baseline until the end of study (maximum duration: 1059 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place